Field
The invention relates to a test disk system having at least one test disk for testing the condition of a seal of a glove which is installed in a port of an isolator.
A test disk system of this type is used for checking the condition of gloves which are installed in ports of isolators.
Description of the Related Art
Isolators are needed in various industrial sectors, for example in chemistry, pharmacy, nuclear technology but also in medicine, in order to produce a volume which is separate from the surroundings, in which selected substances can be kept and manipulated, for example subjected to chemical reactions, the transport of substances in (at least) one direction (from the isolator to the surroundings or from the surroundings to the isolator) being prevented.
Preventing the transport of substances from the isolator into the surroundings is necessary, for example, when radioactive substances or powdery chemicals are kept and handled in the isolator. Isolators in the nuclear sector (glove boxes) are operated with a high negative pressure in order to avoid the escape of radioactive substances into the surroundings under all circumstances. On the other hand, in the case of chemicals, a lower negative pressure relative to atmospheric pressure is sufficient.
Transport of substances from the surroundings into the isolator, on the other hand, must be prevented in particular in the case of isolators for aseptic pharmaceutical processes, in order to avoid contamination of the isolator volume or interior with germs from the surroundings. For this purpose, even a relatively low positive pressure relative to atmospheric pressure is sufficient.
In both cases, the handling of the substances in the isolator is preferably carried out with the aid of remotely controlled mechanical manipulators. However, there are many processes in which such automation is not possible or possible only with unacceptably high costs, so it is not possible to dispense with humans as operators. The access of the operator to the interior of the isolator is carried out via apertures in the wall of the isolator, so-called ports, which are equipped with flexible, hermetically tightly clamped-in gloves made of a sufficiently resistive material. The gloves are able firstly to ensure the seal (integrity) of the isolator volume but also to give the operator the necessary freedom of movement in order to carry out the necessary manipulations in the interior.
Any fault with the integrity of the isolator is subject to economic or even health risks. If, for example, germs from the surroundings penetrate into the isolator, then an entire batch of aseptically produced pharmaceutical products can become unusable. If, in the converse case, toxic substances escape from the isolator, then they can endanger the operator and the surroundings. Therefore, such faults must be prevented without fail and, if they nevertheless occur despite all countermeasures, must be detected and eliminated immediately.
By means of test disks which are inserted into the ports of an isolator, it is now possible to check the intactness or seal of the gloves installed on the port. A suitable test disk system is known, for example from EP 2 741 067 from the applicant. Here, a test disk matched to the shape of a port is inserted into the port in order to pressurize a volume of the glove connected to the port. Monitoring of the pressure profile then follows, a pressure loss leading to the glove being scrapped if it exceeds a certain limiting value. In order to be able to demonstrate which port with which glove the test disk is currently testing, the test disk is provided with a reading device which reads identification elements of the glove and of the port and assigns the same to the pressure data determined. The respective test disks can always be inserted only into ports of one size. In the case of installations having different port sizes, this solution is therefore relatively complicated. Furthermore, a power supply of the components of the test disks which, for example, is achieved via externally connectable accumulators, requires additional interfaces that are susceptible to contamination. In addition, the test disks become relatively cumbersome as a result.